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Tersolisib + Abemaciclib for Breast Cancer

(PIKALO-3 Trial)

Not yet recruiting at 8 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to compare two ways of giving the anti-cancer medicines abemaciclib and hormone therapy with tersolisib in participants with early breast cancer that has a genetic mutation (PIK3CA mutation).

For each participant, the study will last up to 56 weeks and include 12 visits.

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people with early-stage breast cancer that has a specific genetic change called a PIK3CA mutation. Participants should not have advanced or metastatic disease and must meet general health requirements set by the study team.

Inclusion Criteria

Are willing to follow contraception requirements
I have had up to 12 weeks of hormone therapy before joining the study.
I have HR+ HER2- breast cancer on both sides and had proper surgery for all tumors.
See 6 more

Exclusion Criteria

I currently have an active Hepatitis C infection.
I have had a cancer other than breast cancer.
I currently have an active Hepatitis B infection.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Abemaciclib
  • Anastrozole
  • Exemestane
  • Letrozole
  • Tersolisib (LY4064809)

Trial Overview

The study compares two treatment approaches: one group receives abemaciclib plus hormone therapy, while the other gets abemaciclib, hormone therapy, and an additional drug called tersolisib. Treatments are given over about a year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm B: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - ConcurrentExperimental Treatment5 Interventions
Group II: Arm A: Abemaciclib and Endocrine Therapy (ET) + Tersolisib - StaggeredExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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